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Spinning Seralini: why controversial GM study must not be ignored

Regulatory authorities must ditch double standards and push for more research

Bravery, stupidity, or vested interests? These are some possible characteristics of those who are desperately trying to force the retraction of the study by Séralini et al about the long-term risks of eating genetically modified (GM) crops. As we indicated in our previous article on the subject, the study wasn’t perfect. Few are. But what’s needed is more research – not burial of Séralini et al’s findings. But will the European Food Safety Authority (EFSA) listen?

Enter EFSA

EFSA published its initial review on 4th October, declaring Séralini's paper to be, “[Of] insufficient scientific quality to be considered as valid for risk assessment”. Its criticisms included several of the points made by the Science Media Centre, ourselves and others, and went further. EFSA alleged, among other things, that the authors had not followed specific Organisation for Economic Cooperation and Development (OECD) guidelines specifying a minimum of 50 rats per group for an experiment such as this. The Authority asked for further information in advance of its final determination, promised for the end of October 2012.

Cloak and dagger science

At this point, it is useful to highlight that Prof Séralini had felt compelled to perform his experiment under conditions of strict secrecy, to avoid it being scuppered by the biotech industry. The study authors even took the unusual, and unpopular, step of asking journalists to sign a non-disclosure agreement prior to receiving the study text.

In this context, what happened next is less surprising: Prof Séralini refused to hand over his data to EFSA, claiming that his study exceeded the level of scientific rigour employed in the studies used by EFSA to approve many GM crops. Publicly release all of the data relating to GM crop approvals, said Séralini to EFSA, and I will do the same – then we can all see who is doing the 'best' science on GM crops.

Bad faith

On 22nd October, EFSA complied with Séralini's request, or so it claimed. But, in a French article translated by GM Watch, Séralini's group accused EFSA of “bad faith”: “There are no biological data (analyses of blood and tissues) on which you can work. This is really a con trick".

NGO to the rescue

In the absence of definitive data from EFSA, it was left to the non-governmental organisation Testbiotech to take a close look at the studies EFSA deemed acceptable for approval of GM crops – and to compare them with Séralini's paper. Its report, entitled The double standards of EFSA, is essential reading for anyone wishing to understand the finer details of this affair.

The report points out that EFSA has been inconsistent when handling scientific research. When it's a GM crop produced by Monsanto and other biotech companies, EFSA has happily accepted scientific standards well below those the Authority now chooses to apply to Séralini's paper. According to Testbiotech, “EFSA does not apply OECD standards to sub-chronic, 90 day feeding studies when these are prepared by industry and do not show health effects from consuming genetically engineered foods. In contrast, the OECD standards have been used by EFSA to attack the research of Séralini et al”.

Double standards

It's the same picture with chronic and generational feeding studies – even though, “Very few have so far been conducted using plants that are actually authorised in the EU and assessed by EFSA”. Testbiotech examined several such studies and concluded: “None of [the papers] describing chronic feeding studies with genetically engineered plants have met the standards being used by EFSA to criticize the research of Séralini et al., 2012”. Table 1 illustrates this point by comparing the Séralini paper with several trials included in a review of chronic and generational studies, performed by Snell et al, which EFSA accepted. The Snell review is often used to defend the long-term safety of GM crops by the biotech industry and regulators. EFSA, of course, doesn't see any of this as double standards at all.

Table 1. Comparison of the Séralini et al study on GM maize NK603 and Roundup fertiliser with other long-term feeding studies on GM plants, which have been accepted by EFSA. From Testbiotech backgrounder, The double standards of EFSA.

No-one is saying that the Séralini et al paper was perfect, but it's becoming clearer every day that it should be used as a launchpad for further research. Unfortunately, to us, this looks like the story of Dr Arpad Pusztai all over again. Let's hope that there's a better outcome this time, for the sake of science and public health. We will, of course, keep you informed.

Call to action

Write to Elisabeth Waigmann, head of the EFSA’s GMO panel (e-mail: [email protected]) and demand that EFSA apply the same standards when assessing the evidence about GM crops, whether it comes from the biotech industry or from independent scientists. You may also wish to ask why EFSA has condemned the Séralini et al paper as being of such poor quality that it cannot contribute to risk assessment, when it has accepted other papers written to a lower level of scientific rigour than Séralini's, and if EFSA intends to release the remaining data requested by Prof Séralini. Finally, you could ask EFSA whether it is prepared to ignore the Séralini et al paper altogether, or if it will push for the study to be replicated by an independent group, either under identical conditions or under conditions that EFSA deems acceptable. We suggest that you copy your email to EFSA’s executive director, Catherine Geslain-Lanéelle (e-mail: [email protected]) and Dr. Djien Liem, Head of EFSA's Scientific Committee (e-mail: [email protected])

You could also address these questions to your MEP for she or he to raise with EFSA. The more directions used, the more likely it is that EFSA will be forced to respond.

Comments

your voice counts

Arnaldo Andrade
02 December 2012 at
12:17 am

Séralini´s paper is rubbish. As a scientific paper it is utterly useless. On the other hand it helped propel anti-OGM people into yet another anti-science campaign. For Séralini it was great and helped him cope with the funding he got to write this thoroughly weak study. Science is the bigger loser in this affair and concerned ecologists are also losers because the more you go away from science the closer you come to obscurantism.

ANH Admin
18 December 2012 at
2:57 pm

The paper has weaknesses, but we don't agree it is rubbish. If it points to a possible effect it isn't rubbish in our view. We were one of very few anti-GMO groups which were in any way critical (http://anhinternational.org/news/anh-feature-french-study-indicates-monsanto-maize-and-roundup-cause-cancer) of the methodologies used by Séralini et al. We think it's reckless - and even unscientific - to dismiss the findings of Séralini totally - especially if this means avoiding doing any further studies that attempt to evaluate lifetime risks in an animal model. After what happened to Arpad Pusztai, it is no surprise that Séralini has been attacked. The issues raised by Séralini would be much more productively handled by carrying out more lifetime studies as conducted by Pusztai and Séralini, but with larger number's, better statistical power, and using independent researchers - or better still - making it multi-centre.

ISN
02 December 2013 at
3:27 am

If you look at the data in figure 1. of the report you will see that the data demonstrates that glyphosate in water leads to lower mortality rates in male mice (bottom left panel)... you will see that, according to the data, the higher concentrations of GMO maize (22% and 33%) led to lower mortality rates than the lowest (11%) or zero concentrations of GMO maize (top left panel)... If you look at any of the other 4 panels (female GMO/GMO+R/R and male GMO+R), you will see that the highest concentrations of GMO/GMO+R/R always lead to lower mortality rates than at least one of the lower concentrations... You say "If it points to a possible effect it isn't rubbish in our view." Well, if anything (which honestly the study is so badly designed- tumor-prone mice, really? that small of a control, really?- and the results demonstrate no consistent trends so no conclusions should be drawn from it), the data appears to point to the complete opposite conclusion than what the authors try to get away with. I can't believe the report made it past peer-review to begin with.

ISN
02 December 2013 at
3:30 am

I can't see if my comment is being posted or not.. sorry if this is a double post. If you look at the data in figure 1. of the report you will see that the data demonstrates that glyphosate in water leads to lower mortality rates in male mice (bottom left panel)... you will see that, according to the data, the higher concentrations of GMO maize (22% and 33%) led to lower mortality rates than the lowest (11%) or zero concentrations of GMO maize (top left panel)... If you look at any of the other 4 panels (female GMO/GMO+R/R and male GMO+R), you will see that the highest concentrations of GMO/GMO+R/R always lead to lower mortality rates than at least one of the lower concentrations... You say "If it points to a possible effect it isn't rubbish in our view." Well, if anything (which honestly the study is so badly designed- tumor-prone mice, really? that small of a control, really?- and the results demonstrate no consistent trends so no conclusions should be drawn from it), the data appears to point to the complete opposite conclusion than what the authors try to get away with. I can't believe the report made it past peer-review to begin with.

ANH Admin
20 January 2014 at
6:35 pm

Hi ISN, thanks for your message. We’d strongly advise you to read Séralini’s own rebuttal of these criticisms at www.gmoseralini.org: http://gmoseralini.org/criticism-seralinis-study-was-so-badly-designed-that-no-conclusions-can-be-drawn-from-it/. The frequently asked questions about the study - http://gmoseralini.org/faq-items/ten-things-you-need-to-know-about-the-seralini-study/ - contain plenty more information clearly demonstrating that: the Séralini et al 2012 paper was a toxicity study that was not designed to assess carcinogenicity; that the experimental design was appropriate for a toxicity study; that the Séralini protocol merely extended Monsanto’s own protocol that was deemed acceptable for approval of NK603 maize by the European Food Safety Authority in the first place; and that the choice of rat strain and control group size was also appropriate, among other important aspects. Given that no regulatory anywhere in the world demands GM animal feeding trials that extend beyond 90 days, equivalent to around 7-9 years in humans, it is astonishing that Séralini et al’s lifetime rat feeding trial has attracted so much ire - especially when the tumours only became apparent after 4 months. Put another way, the existing regulatory standards could not possibly have observed these tumours occurring, because their duration is too short - and yet Séralini is called a charlatan for performing a more rigorous study that threw up worrying findings. Something is very wrong here.

Finally, don’t forget that Séralini did not act alone: he headed up a team of researchers, working out of a respected academic institution, the University of Caen in France. It is it highly unlikely that an entire group of charlatans would be able to obtain funding, perform, write up and publish shoddy or fraudulent work in such an environment. Not only that, but the experimental would have been thoroughly examined before approval by the university’s ethics committee.

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